NCT06655480 Triple Combination Therapy (ARNI, SGLT2i, MRA) in Advanced HFpEF

Trial Parameters

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Brief Summary

Patients with advanced heart failure with preserved ejection fraction (HFpEF) will be randomly assigned in open-label multicenter study to receive triple combination therapy with \[angiotensin receptor/neprilysin inhibitor \[ARNI\] + sodium-glucose cotransporter 2 inhibitor \[SGLTi\] + mineralocorticoid receptor antagonist \[MRA\]) or with individualized medical therapy \[SGLTi + renin-angiotensin system inhibitor \[RASi\] \[angiotensin receptor blocker \[ARB\] or angiotensin-converting enzyme inhibitor \[ACE-I\]), and will be treated for 52 weeks

Eligibility Criteria

Inclusion Criteria: 1. Signed and data informed consent; 2. Symptoms and signs of HF; 3. LV ejection fraction \> 50%; 4. NT-proBNP \> 300 pg/mL (for patients with atrial fibrillation NT-proBNP \> 900 pg/mL) 5. LV diastolic dysfunction II-III grade OR LV diastolic dysfunction I grade and at least 2 out of 4: * Е/е' \> 14 * LAVi \> 34 ml/m2 (for those with persistent atrial fibrillation \> 40 ml/m2) * PASP \> 35 mm Hg or TR velocity \> 2.8 m/sec * LV mass index \> 95 g/m2 for women / \> 115 g/m2 for men or LV interventricular septum or posterior wall thickness ≥ 1.1 sm OR Chronic atrial fibrillation and at least 3 out of 4: * Е/е' \> 11 * E-wave velocity \> 100 sm/s * TR velocity \> 2.8 sm/s * DT ≤ 160 ms Exclusion Criteria: 1. Evidence of myocardial ischemia during stress echocardiography; 2. Significant lesions of main coronary arteries; 3. Atrial fibrillation with resting HR \> 110 beats/min; 4. Continuous (\>90 days) treatment with ARNI, SGLTi and/or AMR within 12 months prior to scr

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